STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS 

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT 

OFFICE OF AIR RESOURCES 

AIR POLLUTION CONTROL REGULATION NO. 26 

CONTROL OF ORGANIC SOL VENT EMISSIONS 

FROM MANUFACTURERS OF 

SYNTHESIZED PHARMACEUTICAL PRODUCTS 

Effective 19 Novemberl992 

Last Amended 19 July 2007 

AUTHORITY: These regulations are authorized pursuant to R.I. Gen. Laws§ 42-l 7.l-2(s) and 23-23, 

as amended, and have been promulgated pursuant to the procedures set forth in the R.I. Administrative 

Procedures Act, R.I. Gen. Laws Chapter 42-35. 
RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT 

OFFICE OF AIR RESOURCES 

AIR POLLUTION CONTROL REGULATION NO. 26 

CONTROL OF ORGANIC SOL VENT EMISSIONS FROM MANUFACTURE OF 

SYNTHESIZED PHARMACEUTICAL PRODUCTS 

TABLE OF CONTENTS 

26. l Definitions ....................................................................................................................................................... l 

26.2 Applicability .................................................................................................................................................... 2 

26.3 Standards ......................................................................................................................................................... 2 

26.4 Test Methods and Compliance Procedures ....................................................................................................... 4 

26.5 Monitoring for Air Pollution Control Equipment. ............................................................................................. 6 

26.6 Recordkeeping ................................................................................................................................................. 6 

26.7 Reporting ......................................................................................................................................................... 7 

26.8 General Provisions ........................................................................................................................................... 9 

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RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT 

OFFICE OF AIR RESOURCES 

AIR POLLUTION CONTROL REGULATION NO. 26 

CONTROL OF ORGANIC SOLVENT EMISSIONS FROM MANUFACTURE OF 

SYNTHESIZED PHARMACEUTICAL PRODUCTS 

26.1 Definitions 

Unless otherwise expressly defined in this section, the terms used in this regulation shall be 

defined by reference to the Rhode Island Air Pollution Control General Definitions 

Regulation. As used in this regulation, the following terms shall, where the context 

permits, be construed as follows: 

26.1.1 "Condenser" means any device which cools a gas stream to a 

temperature which removes specific voe by condensation. 

26.1.2 "Control System" means any number of control devices, including 

condensers, which are designed and operated to reduce the quantity ofVOe 

emitted to the atmosphere. 

26.1.3 "Enclose" means to cover a volatile organic liquid surface in a manner 

such that it is not exposed to the atmosphere. 

26.1.4 "Pharmaceutical Product and Intermediate" means any drug or 

chemical substance or any intermediate used to make a drug or chemical 

substance which is intended to be administered to a person or animal to prevent or 

cure disease or otherwise enhance physical or mental welfare. 

26.1.5 "Production equipment exhaust system" means a device for collecting and 

directing out of the work area VOC fugitive emissions from reactor openings, 

centrifuge openings, and other vessel openings for the purpose of protecting 

workers from excessive voe exposure. . 

26.1.6 "Reactor" means a vat or vessel, which may be jacketed to permit 

temperature control, designed to contain chemical reactions. 

26. l. 7 "Separation operation" means a physical or chemical process that 

separates a mixture of compounds and solvents into two or more components. 

Specific mechanisms include but are not limited to: extraction, centrifugation, 

filtration, and crystallization. 

26.1.8 "Synthesized pharmaceutical manufacturing" means manufacture of 

pharmaceutical products and intermediates by chemical synthesis. The 

production and recovery of materials produced via fermentation, extraction of 

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organic chemicals from vegetative materials or animal tissues, and formulation 

and packaging of the product are not considered synthesized pharmaceutical 

manufacturing. · 

26.2 Applicability 

26.2.1 This regulation applies to the following sources of volatile organic 

compounds (VOC) at all synthesized pharmaceutical manufacturing facilities: 

(a) Reactors; 

(b) Distillation operations; 

( c) Crystallizers; 

( d) Centrifuges; 

( e) Vacuum dryers; 

(f) Air dryers; 

(g) Production equipment exhaust systems; 

(h) Rotary vacuum filters and other filters; 

(i) Storage tanks; 

G) In-process tanks; and 

(k) Leaks. 

26.2.2 The owner or operator of a synthesized pharmaceutical manufacturing 

facility subject to this regulation shall control the voe emissions from each vent 

which has the potential to emit 15 pounds per day [lb/day] (6.8 kilograms per day 

(kg/day)) or more of voe from reactors, distillation operations, crystallizers, 

centrifuges, and vacuum dryers. voe emissions shall be controlled in accordance 

with the requirements in Section 26.3. 

26.2.3 Where e:vertheterm "Volatile Organic Compound" or "VOC" is used in 

Sections 26.2 through 26.7, t:ras term should be read as "Volatile Organic Compound 

and Halogenated Organic Compound" or "VOC aHd HOC". 

26.2.4 An owner or operator of a facility which has sources whose emissions are 

below the threshold in Subsection 26.2.2 shall comply with the certification, 

recordkeeping, and reporting requirements in Sections 26.6 and 26. 7 for those 

sources. 

26.2.5 Any facility or source that becomes or is currently subject to the provisions 

of this regulation by exceeding the applicability threshold in Subsection 26.2.2 will 

remain subject to this regulation even if the emissions later fall below the 

applicability threshold. 

26.3 Standards 

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By 19 November 1994 the following emissions limitations must be met. Any new source 

commencing operation after 19November1992 must meet the following emission 

limitations upon commencing operations: 

26.3.l Surface condensers or equivalent controls. 

(a) If surface condensers are used, the condenser outlet gas temperature shall not 

exceed the allowable temperature limit described for each associated vapor 

pressure in the following table; or 

Allowable condenser outlet gas voe vapor pressure at 

temperature, EC 20EC, kPa (psi) 

-25 >40.01 (5.8) 

-15 >20.0 (2.9) 

0 >10.0 (1.5) 

10 >7.0 (1.0) 

25 >3.5 (0.5) 

(b) If other controls such as carbon absorption or incineration are used, the voe 

emissions shall be reduced by at least as much as they would be by using a 

surface condenser. All such controls J;llUSt be approved by the Department. 

26.3.2 Air dryers and production equipment exhaust systems. 

The owner or operator of a synthesized pharmaceutical manufacturing facility 

subject to this regulation shall reduce the voe emissions from all air dryers and 

production equipment exhaust systems: 

(a) By at least 90 percent on an hourly basis if actual emissions from all air 

dryers and production equipment exhaust are 150 kg/day (330 lb/day) or 

more of voe or 

(b) To 15.0 kg/day (33 lb/day) or less if actual emissions from all air dryers and 

production equipment exhaust are less than 150 kg/day (330 lb/day) ofVOC. 

26.3.3 Storage Tanks. 

The owner or operator of a synthesized pharmaceutical manufacturing facility 

subject to this regulation shall reduce the voe emissions from storage tanks by: 

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(a) Providing a vapor balance system or equivalent control that is at least 

90 percent effective in reducing emissions from truck or railcar deliveries to 

storage tanks with capacities greater than 7,500 liters (L) (2,000 gallons 

[gal]) that store VOC with vapor pressures greater than 28.0 kiloPascals 

(kPa) (4.1 pounds per square inch [psi]) at 20EC (68EF); and 

(b) Installing pressure/vacuum conservation vents set at a minimum pressure of 

0.2 k.Pa (0.03 pounds per square inch atmospheric [psia]) on all storage tanks 

that store VOC with vapor pressures greater than 10.0 kPa (1.5 psi) at 20EC 

(68EF). 

26.3.4 Centrifuges, rotary vacuum filters, and other filters. 

The owner or operator of a synthesized phannaceutical facility subject to this 

regulation shall enclose all centrifuges, rotary vacuum filters, and other filters having 

an exposed liquid surface if the liquid contains voe and exerts a total voe vapor 

pressure of 3.50 kPa (0.5 psi) or more at 20EC (68EF), as determined by ASTM 

D2879-83. 

26.3.5 In-process tanks. 

The owner or operator of a synthesized phannaceutical facility subject to this 

regulation shall install covers on all in-process tanks that contain voe at any time. 

These covers shall be constructed of a nonporous or nonabsorbent material and form 

a tight seal with the sides of the tank and have no gaps or holes. These covers shall 

remain closed at all times except when production, sampling, maintenance, or 

inspection procedures require operator access. 

26.3.6 Leaks. 

The owner or operator of a synthesized phannaceutical manufacturing facility 

subject to this regulation shall visually inspect for liquid leaks once per week and 

use a portable voe detector to inspect for vapor leaks once per month to inspect all 

equipment listed in Subsections 26.2.1 (a) through (k). All leaks repairs shall be 

completed as soon as practicable but no later than 15 calendar days after the leak. is 

found. 

26.4 Test Methods and Compliance Procedures 

26.4.1 If a source uses air pollution control equipment to comply with the 

requirements of this regulation, compliance shall be demonstrated in accordance 

with 40 CFR Part 60, Appendix A, Method 18, Method 25, or Method 25A or any 

other EPA approved method which has been approved by the Director. 

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26.4.2 Selection of a method for testing compliance shall be based on consideration 

of total concentration and speciation of the organics present and on consideration of 

the potential presence of interfering gases. Only Method 25, which measures VOC 

as carbon, may be used for determining destruction efficiency of incinerators or 

catalytic incinerators. 

26.4.3 Except as indicated in Subsections (a) and (b), a test shall consist of three 

separate runs, each lasting a minimum of 60 minutes, unless the Director determines 

that process variables dictate shorter sampling times. 

(a) When the test is being done to determine the efficiency of a fixed-bed carbon 

adsorption system with a common exhaust stack for all of the individual 

adsorber vessels, the test shall consist of three separate runs, each coinciding 

with one or more complete sequences through the adsorption cycles of all the 

individual adsorber vessels. 

(b) When the test is being done to determine the efficiency of a fixed-bed carbon 

adsorption system with individual exhaust stacks for each adsorber vessel, 

each adsorber vessel shall be tested individually. The test for each adsorber 

vessel shall consist of three separate runs. Each run shall coincide with one 

or more complete adsorption cycles. 

26.4.4 Method 1 or IA of 40 CFR Part 60, Appendix A, shall be used for velocity 

traverses. 

26.4.5 Method 2, 2A, 2C, or 2D of 40 CFR Part 60, Appendix A, shall be used to 

measure velocity and volumetric flow rates. 

26.4.6 Method 3 or 3A of 40 CFR Part 60, Appendix A, shall be used for 02 and 

C02 analysis. · 

26.4.7 Method 4 of 40 CFR Part 60, Appendix A, shall be used to measure stack 

gas moisture. 

26.4.8 Methods 2, 2A, 2C, 2D, 3, 3A and 4 of 40 CFR Part 60, Appendix A, shall 

be performed, as applicable, at least twice during each test run. 

26.4.9 Use of modifications of any of the analytical methods specified in 

Subsections 26.4. l through 26.4.8 ofthis section shall be approved or disapproved 

by the Director on a case-by-case basis. An owner or operator shall submit 

sufficient documentation for the Director to find that the analytical methods 

specified in Subsections 26.4.1 through 26.4.7 will yield inaccurate results and that 

the proposed modification is appropriate. 

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26.5 Monitoring for Air Pollution Control Equipment. 

26.5.1 At a minimum, continuous monitors measuring the following parameters 

shall be installed on air pollution control equipment used to control sources subject 

to this regulation by [the date two years after the effective date of this regulation]: 

(a) Destruction device combustion temperature; 

(b) Temperature rise across a catalytic incinerator bed; 

( c) V OC concentration at the outlet of a carbon adsorption unit at breakthrough; 

( d) Outlet gas temperature of a refrigerated condenser; and 

( e) Outlet gas temperature of a non-refrigerated condenser coolant supply 

system. 

26.5.2 Each monitor shall be: 

(a) Equipped with a recording device, 

(b) Calibrated quarterly, and 

( c) Operated at all times that the associated control equipment is operating. 

26.6 Recordkeeping 

26.6.1 The owner or operator of a pharmaceutical manufacturing facility subject to 

this shall maintain the following records beginning [the date two years after the 

effective date of this regulation]: 

(a) Recording of pc,l!ameters listed in Subsection 26.5. 

(b) A record of the solvent true vapor pressure as determined by ASTM D2879-

86, for each VOC used in a source which is subject to this regulation. For a 

pure solvent, a record of published data reporting the true vapor pressure of 

that solvent as determined using ASTM D2879-86 is acceptable to fulfill this 

requirement. 

26.6.2 For any leak subject to Subsection 26.3.6, which cannot be readily repaired 

within 24 hours after detection, the following shall be recorded: 

(a) The name of the leaking equipment; 

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(b) The date and time the leak is detected; 

( c) The action taken to repair the leak; and 

( d) The date and time the leak is repaired. 

26.6.3 All records required in this Subsection shall be maintained at the facility for 

a minimum of five years. 

26. 7 Reporting 

26.7. I Initial Compliance Certification Plan 

26. 7. I. I The owner or operator of any facility containing 

sources subject to this regulation shall submit to the Director an 

initial compliance certification plan by [the date one year after the 

effective date of this regulation]. The owner or operator of any 

facility that becomes subject to this regulation after [the date one year 

after the effective date of this regulation] shall submit an initial 

compliance certification for that source immediately upon start-up of 

the operation. 

26. 7 .1.2 The initial compliance certification shall include as a 

minimum the following information: 

(a) The name and location of the facility; 

(b) The name, address and telephone number of the person responsible 

for the facility; 

( c) An identification of subject sources at the facility; 

(d) The information specified in Subsection 26.7.1.3 for each subject 

source; and 

(e) The time at which the facility's "day" begins if a time other than 

midnight local time is used to define a "day". 

26.7.1.3 The initial compliance certification shall also include, 

as a minimum, the following information for each subject source: 

(a) Identification of the applicable emission limitation, equipment 

specification, or work practice, as specified in Section 26.3; 

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(b) The method by which compliance has been or will be achieved; 

(c) For each source subject to numerical emission limitations, the 

estimated actual and potential emissions without control, and the 

basis for the estimate; 

26.7.2 Final Compliance Certification 

26.7.2.1 By 19 November 1994 or immediately upon startup 

for a facility which becomes subject to this regulation after 19 

November 1994, the owner or operator of any facility containing 

sources subject to this regulation shall certify to the Director that the 

facility is in compliance with the provisions of this regulation. 

26. 7 .2.2 The final compliance certification shall include, at a 

minimum, the following information: 

(a) The method by which compliance has been achieved for each subject 

source; 

(b) For each source subject to numerical emission limitations, the 

estimated actual and potential emissions without control, and the 

basis for the estimate; 

(c) Identification of the control system(s) in use for each subject source; 

(d) The design performance efficiency of the control system; 

(e) For each source subject to numerical emission limitations, the 

estimated emissions after control; 

(f) Certification that each subject source at the facility is in compliance 

with the applicable emission limitation, equipment specification, or 

work practice; 

(g) An identification of any changes from the initial compliance 

certification plan. 

26.7.3 Reports of Noncompliance with Standards 

(a) The owner or operator of any facility containing sources subject to this 

section shall, for each incidence of noncompliance with the standards in 

Section 26.3, within 30 calendar days of becoming aware of such 

occurrence, supply the Director with the following information: 

(i) The name and location of the facility; 

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(ii) The subject source(s) that caused the noncompliance with the 

standard; 

(iii) The time and date of first observation of 

the incident of noncompliance; 

(iv) The cause and expected duration of the incident of noncompliance; 

(v) For sources subject to numerical emission limitations, the estimated 

rateof emissions (expressed in the units of the applicable emission 

limitation) during the incident and the operating data and calculations 

used in estimating the emission rate. 

(vi) The proposed corrective actions and schedule to correct the 

conditions causing the incidence of noncompliance. 

26.8 General Provisions 

26.8.1 

26.8.2 

26.8.3 

26.8.4 

Purpose 

The purpose of this regulation is to limit volatile organic compound 

emissions from the manufacture of synthesized pharmaceutical products 

Authority 

These regulations are authorized pursilant to RI. Gen. Laws § 42-l 7. l-2(s) 

and 23-23, as amended, and have been promulgated pursuant to the 

procedures set forth in the R.I. Administrative Procedures Act, R.I. Gen. 

Laws Chapter 42-35 

Application 

The terms and provisions of this regulation shall be liberally construed to 

permit the Department to effectuate the purposes of state law, goals and 

policies. 

Severability 

If any provision of this regulation or the application thereof to any person or 

circumstance, is held invalid by a court of competent jurisdiction, the 

validity of the remainder of the regulation shall not be affected thereby. 

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26.8.5 

Notice Given on: 

Public Hearing held: 

Filing Date: 

Effective Date: 

Effective Date 

The foregoing regulation, "Control of Organic Solvent Emissions from 

Manufacturers of Synthesized Pharmaceutical Products", as amended, is 

hereby adopted and filed with the Secretary of State this 12th day of 

February, 2015, in accordance with the provisions of Chapters 23-23, 42-35, 

42-17.1, 42-17.6, of the General Laws of Rhode Island of 1956, as amended. 

Janet Coit, Director 

Department of Environmental Management 

February 21, 2007 

March 23, 2007 

June 29, 2007 

July 19, 2007 

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